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NCT Number: NCT05742906

CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients. The main question(s) it aims to answer are:

* whether the device may be implanted successfully and safely, and * whether the device effectively treats tricuspid valve disease and dysfunction through 12 months

Participants will undergo:

* preoperative evaluation * tricuspid valve replacement with the Cor TRICUSPID ECM Valve * postoperative evaluation, including at hospital discharge, 30 days, 6 months, and 12 months, and then annually thereafter through 5 years

Recruiting

Interested in participating?

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Key information

Conditions

Tricuspid Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Francis Hospital, Indianapolis, Indiana, United States

Loading trial locations.

About this study

CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the Cor TRICUSPID ECM Valve for adults and the Cor PEDIATRIC Tricuspid ECM Valve for pediatrics (collectively these devices will be referred to as the Cor TRICUSPID ECM Valve(s)), which can be implanted to replace dysfunctional tricuspid heart valves. The objective of this Pivotal Study is to collect safety and effectiveness data on surgical tricuspid valve replacement procedures using the Cor TRICUSPID ECM valve to support a Humanitarian Device Exemption (HDE) marketing application.

Because the majority of tricuspid valve replacements (TVRs) (approximately 80%) are performed concomitantly with other cardiac operations, including replacements of mitral or aortic valves, it is anticipated that a portion of study subjects will require concomitant replacement or repair of a dysfunctional mitral or aortic valve, based on the clinical judgment of the investigator.

Therefore, safety with the Cor TRICUSPID ECM Valve will be established by Procedural, Technical and Device Success.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
  • Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent and the pediatric patient (if applicable) provides written assent (if able) prior to procedure
  • Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfill all of the expected requirements of this clinical protocol
  • Patients where the Cor TRICUSPID ECM Valve will be the physiological right-sided atrioventricular (AV) valve

Exclusion criteria

  • Tricuspid annulus too small (< 10mm) to accommodate the Cor TRICUSPID ECM Valve
  • Left ventricular ejection fraction (LVEF) < 25%
  • Mean pulmonary pressure ≥ 50mmHg or pulmonary vascular resistance greater than 6 Woods Units
  • Emergency cardiac procedure. An example would be a person requiring resuscitation and in cardiogenic shock. An unscheduled or unplanned emergency surgery
  • Cardiac transplant patient
  • Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock
  • Patients with a single ventricle where the Cor TRICUSPID ECM Valve would be the systemic AV valve
  • Documented primary coagulopathy or uncorrected platelet disorder, including thrombocytopenia (absolute platelet count < 30k). Patient can be enrolled regardless of these parameters if in the opinion of the Investigating Surgeon the coagulopathy can be adequately reversed by transfusions. An example would be the reversal of thrombocytopenia by transfusion of platelets
  • Documented evidence of intrinsic hepatic disease (defined as liver enzyme values (aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin) that are > 5 times the upper limit of reference range within 30 days of enrollment, except in association with acute/reversible decompensation as determined by the Investigator)
  • Documented evidence of significant renal dysfunction (serum creatinine > 4.0mg/dl or GFR< 30 on the modified Schwartz formula)
  • Stroke within 30 days prior to enrollment
  • Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA)) that has a life expectancy of less than one year
  • Known cancer (cancer-free ≤ 1 year; does not include non-metastatic basal cell carcinoma or cervical carcinoma) and/or undergoing treatment including chemotherapy and radiotherapy
  • Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow suppressant drugs
  • Known sensitivity to porcine materials
  • Contraindication to anticoagulation/antiplatelet therapy (aspirin (ASA) and/or Plavix)
  • Patients who are pregnant (method of assessment Investigator's discretion)
  • Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study, without CorMatrix written approval

Treatment and study plan

Tricuspid valve replacement with the Cor TRICUSPID ECM Valve

Device

Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.

Primary outcomes

  1. Safety Outcome - Procedural Success

    Time frame: 30 days

    Device Success and no tricuspid valve device-related Serious Adverse Events (SAEs)

  2. Effectiveness Outcome - Individual Patient Success

    Time frame: 6 months

    • Device success and
    • no Cor TRICUSPID ECM Valve-related re-hospitalizations or re-interventions of the Cor TRICUSPID ECM Valve (clinically significant: new endocarditis of the tricuspid valve [TV], recurrence of tricuspid regurgitation [TR] > moderate, or right sided heart failure [HF]) unless endocarditis is secondary to recurrent drug abuse.
    • Improvement vs. baseline in symptoms (improvement in New York Heart Association [NYHA] [adult subjects] and clinical improvement [pediatric subjects] Class >/= 1 grade)

  3. Effectiveness Outcome - Individual Patient Success

    Time frame: 12 months

    • Device success and
    • no Cor TRICUSPID ECM Valve-related re-hospitalizations or re-interventions of the Cor TRICUSPID ECM Valve (clinically significant: new endocarditis of the tricuspid valve [TV], recurrence of tricuspid regurgitation [TR] > moderate, or right sided heart failure [HF]) unless endocarditis is secondary to recurrent drug abuse.
    • Improvement vs. baseline in symptoms (improvement in New York Heart Association [NYHA] [adult subjects] and clinical improvement [pediatric subjects] Class >/= 1 grade)

Other outcomes

  1. Technical Success

    Time frame: One week or prior to hospital discharge

    • Alive at exit from OR with:
    • Successful implant of the single intended Cor TRICUSPID ECM Valve
    • No need for additional emergency surgery or re-intervention related to the Cor TRICUSPID ECM Valve device
    • Final post-op transthoracic echocardiogram (TTE) (at 1 week or prior to discharge) shows tricuspid valve regurgitation </= moderate

  2. Device Success

    Time frame: 30 days

    No device-related mortality, with

    • Original intended Cor TRICUSPID ECM Valve in place, and
    • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and
    • Intended performance of the Cor TRICUSPID ECM Valve:
    • No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)
    • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and
    • Expected hemodynamic performance:
    • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
    • Valve regurgitation ≤ moderate

  3. Device Success

    Time frame: 6 months

    No device-related mortality, with

    • Original intended Cor TRICUSPID ECM Valve in place, and
    • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and
    • Intended performance of the Cor TRICUSPID ECM Valve:
    • No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)
    • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and
    • Expected hemodynamic performance:
    • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
    • Valve regurgitation ≤ moderate

  4. Device Success

    Time frame: 12 months

    No device-related mortality, with

    • Original intended Cor TRICUSPID ECM Valve in place, and
    • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and
    • Intended performance of the Cor TRICUSPID ECM Valve:
    • No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)
    • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and
    • Expected hemodynamic performance:
    • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
    • Valve regurgitation ≤ moderate

  5. Device Success

    Time frame: 24 months

    No device-related mortality, with

    • Original intended Cor TRICUSPID ECM Valve in place, and
    • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and
    • Intended performance of the Cor TRICUSPID ECM Valve:
    • No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)
    • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and
    • Expected hemodynamic performance:
    • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
    • Valve regurgitation ≤ moderate

  6. Device Success

    Time frame: 36 months

    No device-related mortality, with

    • Original intended Cor TRICUSPID ECM Valve in place, and
    • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and
    • Intended performance of the Cor TRICUSPID ECM Valve:
    • No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)
    • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and
    • Expected hemodynamic performance:
    • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
    • Valve regurgitation ≤ moderate

  7. Device Success

    Time frame: 48 months

    No device-related mortality, with

    • Original intended Cor TRICUSPID ECM Valve in place, and
    • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and
    • Intended performance of the Cor TRICUSPID ECM Valve:
    • No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)
    • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and
    • Expected hemodynamic performance:
    • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
    • Valve regurgitation ≤ moderate

  8. Device Success

    Time frame: 60 months

    No device-related mortality, with

    • Original intended Cor TRICUSPID ECM Valve in place, and
    • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and
    • Intended performance of the Cor TRICUSPID ECM Valve:
    • No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)
    • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and
    • Expected hemodynamic performance:
    • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
    • Valve regurgitation ≤ moderate

Study contacts

Contact information is provided by the study sponsor or research team.

Brad Solberg, MBA

CONTACT

[email protected]

4084644001

Robert G Matheny, MD

CONTACT

[email protected]

404-276-7777

Sponsors and collaborators

Lead sponsor

Corvivo Cardiovascular, Inc.

Industry

Collaborators

  • Yale University

Registry information

Official study title

CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2023
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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